Legacy device transition: applicability under MedDO Art. 101 and IvDO Art. 82

This article is part of the 50-article series on medical device registration in Switzerland, Volume 2 (Premarket Pathways and Strategy), and is the fifteenth instalment; together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are shown in the table below.

1. Key takeaways

Whether a legacy device may continue to be sold in Switzerland depends on two variables: the type of certificate (an MDD/AIMDD certificate or an IVDD certificate) and the risk class. MedDO Art. 101 and IvDO Art. 82(1) each govern a separate line, and their calendars cannot be borrowed from one another. The decision sequence is first to establish which ordinance applies, then to read off the class-based cut-off and the certificate issue date within that ordinance. Treating the two lines as interchangeable is the single most expensive classification error in legacy planning, because the IVD calendar runs a full year longer for some classes than the device calendar does.

The two variables must be resolved for every single item in the portfolio: the certificate line and the ordinance line are read independently, and the binding date for each item is the earliest of the dates that emerge. A portfolio-level average is not a compliant answer.

2. Legal basis

3. Expert insights

1. The two ordinances use different class bands, and mixing them miscalculates the cut-off. On the MedDO side, high-risk devices run to 31 December 2027 and medium and low-risk devices to 31 December 2028; on the IvDO side the banding has three tiers — Class D to December 2027, Class C to December 2028, and Class B and sterile Class A to December 2029. Estimating an IVD product against the two-band MedDO calendar wastes at least one year of window, or forfeits one, depending on which way the error runs.
2. The independent cut-off for code certificates is easy to overlook. Code certificates issued between 25 May 2017 and 25 May 2022 remain valid until 31 December 2027; this date applies in parallel with the risk-class calendar, and the earlier date governs. A company that tracks only the class calendar may find the certificate lapsing first and be caught without a fallback.
3. The break in the MRA changed the strategic meaning of the transition period. Chapter 4 of the Switzerland–EU MRA has not been renewed by the EU since May 2021, and Switzerland is treated as a third country in the medical device field. The transition period has therefore changed purpose: from bridging to the EU, to buying time for Swiss local entity arrangements (CH-REP, CHRN, swissdamed). On 2 March 2026 the two sides signed a package containing a protocol revising the MRA, but it enters into force only after ratification by both parties, and industry expects entry into force no earlier than 2028 (practical estimate); until then the status quo applies.
4. The abolition of the sell-off deadline is a double-edged sword. Both ordinances have removed the sell-off period. The favourable side is that there is no forced-destruction date for stock after expiry; the unfavourable side is that once the transition period lapses there is no buffer at all — stock already pushed into the channel immediately loses its legal basis for sale, and the cost of channel returns and recalls must be provisioned in advance.

4. Practical recommendations

1. Build a three-dimensional ledger per item — certificate, class, ordinance — deciding the ordinance first (MedDO or IvDO) and only then applying that ordinance’s banded calendar.
2. Flag code certificates issued between 25 May 2017 and 25 May 2022 separately with the earlier cut-off of 31 December 2027.
3. Plan the channel backwards from the absence of a sell-off deadline: treat the transition expiry date as the final point for clearing channel stock, not as a date after which selling may continue.
4. Advance the Swiss entity arrangements (CH-REP mandate, CHRN, swissdamed registration) in parallel during the transition, without waiting for the outcome of the MRA renewal.
5. Keep the quality system, with ISO 13485 as one of its baselines, operating effectively as the evidence chain of continuous compliance through the transition.

5. Verification checklist

• □ For every legacy device it has been determined whether MedDO or IvDO applies, with no cross-ordinance use of the calendars.
• □ Cut-offs have been flagged per ordinance banding: MedDO high-risk 31 December 2027, medium and low-risk 31 December 2028.
• □ IVD products have been checked against the Class D/C/B and sterile A bands, including the December 2029 milestone.
• □ Code certificates (issued 25 May 2017 to 25 May 2022) have been flagged separately with 31 December 2027.
• □ Channel and stock plans have been reworked on the no-sell-off-period basis.
• □ Quality system certification (ISO 13485 and similar) is within its validity period.

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Swiss market with registration pathway and classification strategy services, including legacy device ordinance triage across MedDO Art. 101 and IvDO Art. 82(1) and transition project planning. For support with your legacy portfolio in Switzerland, contact GRZAN at info@grzanglobal.com.